INTERVENTIONS TO IMPROVE HYPERTENSION CONTROL RATES IN AFRICAN AMERICANS
RELEASE DATE: September 2, 2003
RFA Number: RFA-HL-04-007
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.837
LETTER OF INTENT RECEIPT DATE: December 23, 2003
APPLICATION RECEIPT DATE: January 20, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Heart, Lung, and Blood Institute invites applications for research
project grants (R01) to evaluate clinically feasible interventions to effect
changes in medical care delivery leading to an increase in the proportion of
treated hypertensive African American patients whose blood pressure is
controlled to levels specified by Joint National Committee on Prevention,
Detection, Evaluation and Treatment of High Blood Pressure (JNC) guidelines.
The ultimate goal is to prevent complications of hypertension, and thus increase
quality and years of healthy life in African Americans - a group with highest
prevalence and earliest onset of hypertension, and disparately high premature
cardiovascular mortality and morbidity. For the purpose of this initiative,
components of medical care delivery consist of patients, clinicians,
interactions between patients and clinicians, and physical, social and
administrative environments in which these interactions occur.
This solicitation addresses both overarching goals of Healthy People 2010
http://www.healthypeople.gov (increasing quality and years of healthy
life, and eliminating health disparities) and is responsive to the first of two
research needs recommendations of the 2002 IOM report, Unequal Treatment
http://www.iom.edu/includes/dbfile.asp?id=4175 (Recommendation 8-1:
Conduct further research to identify sources of racial and ethnic disparities
and assess promising intervention strategies), and to the first of the eight
top-tier priorities of the 2001 NHLBI Task Force Report on Research in
Prevention of CVD http://www.nhlbi.nih.gov/resources/docs/cvdrpt.htm (Evaluate
approaches to enhance implementation of efficacious preventive interventions in
medical systems at all stages of clinical practice).
RESEARCH OBJECTIVES
Background
Cardiovascular mortality rates in African Americans for ages 35-64 are more than
twice those in Caucasians, and for men the gap has increased since 1960. While
some of this disparity may be explained by more frequent poverty among African
Americans, a recent report based on a national probability sample of over
600,000 persons identified hypertension as the single initiating cause of death
independent of socioeconomic status that contributed the most to the racial
disparity between African Americans and Caucasians in potential life-years lost.
The 1999-2000 National Health and Nutrition Evaluation Survey (NHANES) data
reveal low rates of hypertension control in treated African American men and
women, in addition to a long-recognized high prevalence of hypertension (defined
as BP>140/90 mm Hg or current drug treatment). Notably, both observational
(e.g. MRFIT screenees) and clinical trial data (e.g. HDFP) show that
cardiovascular benefit attributable to a given decline in blood pressure is
similar in African Americans and Caucasians.
In NHANES 1999-2000, one out of five African American men age 30-39 had
hypertension (versus one out of eight amongst Caucasian and Mexican American
men). By age 50-59, nearly 60% of African American men were hypertensive
compared to less than 40% of Caucasian and Mexican American men. Prevalence
rates for women aged 30-39 were relatively low for all race/ethnic groups (9%
for African American and 6% for Caucasian and Mexican American women). However,
by age 40-49, nearly half of African American women had hypertension (compared
to one fifth of Caucasian and Mexican American women). In the age group 60-74,
75% of African American men and 81% of African American women had hypertension –
numbers considerably higher than for either Caucasians or Mexican Americans.
In African Americans aged 40 and over, awareness of hypertension was high
(71-83% across gender/age groups) and a large majority of those aware of their
hypertension reported being treated (83-97% across gender/age groups), numbers
similar to those in Caucasians and considerably higher than in Mexican
Americans. However, the proportion of treated African American patients whose
hypertension was controlled to below 140/90 mm Hg remained low (<50%), and in
those aged 40-59 was more than one third lower than in Caucasians (49 versus
75% for men and 41 versus 72% for women). Given the importance of blood
pressure levels in determining future risk of cardiovascular events,
intervention in this age group should lead to a decline in cardiovascular
mortality and morbidity in African Americans, and thus decrease premature
disability.
Efficacious strategies exist for both lifestyle and pharmacological treatment of
hypertension. However, these strategies are not being translated into effective
blood pressure lowering, especially in African American hypertensive patients.
Two important barriers to effective treatment of hypertension in African
Americans, lack of clinical trial data in African Americans on drugs other than
diuretics and cost of drugs, were recently addressed by the results of The
Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial
(ALLHAT). This largest ever antihypertensive treatment trial, which included
15,094 African Americans, determined that thiazide-type diuretics are the
preferred first-step (initial or single drug) therapy for hypertension in both
African American and non-black patients. This evidence and the recent release
of JNC 7 guidelines provide opportune timing to conduct intervention studies
aimed at improving quality of treatment of hypertension in African Americans.
To date, intervention research in African Americans has primarily focused on
bringing individuals with elevated blood pressure levels to medical attention
and increasing patient adherence to prescribed treatment and clinic visits.
Yet, recently published observational studies point to the importance of
additional factors, such as patient experience with clinicians, clinicians'
acceptance of less than optimal blood pressure levels, clinicians' experience
with a variety of antihypertensive medications, patients' participation in
treatment decisions, and commercial influences. While many of these factors may
be common across racial groups, intervention approaches may need to differ to
address race/ethnicity-specific issues, both cultural/social and clinical.
Many hypertensive African American patients are younger than non-African
American due to earlier onset of hypertension. In addition, long-standing
hypertension and associated co-morbidities make selection of treatment regimens
more difficult and may affect adherence due to increased potential for side
effects. Finally, African American patients report less satisfaction with care,
and perceived racial bias, stereotyping, and prejudice continue to affect
quality of care and treatment outcomes. Researchers consistently point to the
need for more culturally acceptable and effective methods of delivering
hypertension care.
Results of three NHLBI-funded randomized studies suggest that clinic-based
programs can successfully increase the proportion of treated hypertensive
African American patients who have adequately controlled blood pressure.
Notably, better hypertension control (62% versus 40-48%) was obtained when the
intervention included change in an institutional environment/culture, feedback
to clinicians, and access to specialized care. In addition, ALLHAT– a large,
simple trial conducted in a variety of primary care settings – achieved blood
pressure control to below 140/90 mm Hg in over 60% of both African American and
non-black patients using organizational-level approaches. While representing
substantial improvements, these rates are far from optimal.
Goals and Scope
This initiative will fund multiple intervention studies aimed to increase the
proportion of treated African American hypertensive patients whose BP levels
meet JNC 7 guidelines (primary outcome). Studies may focus on other special
risk populations only if local and/or national data exist documenting both poor
blood pressure control and disparately high premature morbidity and/or
mortality. Interventions should be institution/clinic-based (including small
practices) and target one or preferably more components of medical care
delivery (patients, clinicians, interactions between patients and clinicians,
and physical, social and administrative environments in which these interactions
occur). However, given prior and ongoing research, interventions targeting
exclusively patient-level variables and/or limited to improving patient
adherence to prescribed treatment, will not be responsive to this RFA.
In general, a randomized design should be used. A quasi-experimental design may
be used if scientifically appropriate and justified. A concurrent control group
is required, and two or more interventions may be compared. If "usual care" is
used as a control group, participants should at minimum receive a copy of JNC 7
treatment guidelines (clinicians) and related patient education materials
(patients). Research plans should take into consideration differences in
practice settings. NOTE: Proposed programs should be feasible and practical for
implementation beyond research settings. Applications should include an
institutionalization phase with evaluation. Also to be included are cost-
effectiveness evaluation and plans for dissemination of study results and
intervention, if successful. If appropriate and representing substantial
opportunity, the investigators are encouraged to include plans for collection
and storage of blood samples, including consent, to be used for genetic,
pharmacogenetic, or other ancillary studies to be conducted in the future and
funded separately. Consideration should be given to collection of other
information that may be needed to make these samples useful in the future.
NOTE: This RFA is not budgeted for any ancillary studies; only collection and
storage of blood specimens (through the end of the study) will be an allowable
expense.
It is estimated that for a patient-randomized trial, a total of about 300
patients would be required to achieve 90% power to detect a difference in blood
pressure control rates between 45% (usual care) and 65% (intervention). For a
clinic-randomized trial (i.e. cluster randomized trial), it is estimated that
about 30 clinics with 30 patients each would be required to detect with 90%
power a difference in blood pressure control rates between 45% (usual care) and
65% (intervention). Clinic-randomized trials must use appropriate statistical
methodology to deal with the hierarchical nature of the data.
Interventions to be tested may include but are not limited to the following
examples:
o one-on-one or small group onsite education (academic detailing) and advice by
opinion leaders
o Use of hypertension treatment guidelines in a patient-oriented context
o Facilitation of patient-clinician interactions
o Specialized teams, academic partnerships
o Continuous quality improvement process
o Access to free or reduced price drugs
o Decision support and reminder systems using information technology
o Multi-component combinations
Program Organization
While the Program will consist of independent research projects, grantees will
meet annually to discuss progress, share experiences and discuss overall
progress of relevant scientific areas. Collaboration amongst investigators will
be encouraged and facilitated, if appropriate.
MECHANISM OF SUPPORT
This RFA will use the NIH R01 award mechanism. As an applicant you will be
solely responsible for planning, directing, and executing the proposed project.
This RFA is a one-time solicitation. Future unsolicited, competing-continuation
applications based on this project will compete with all investigator-initiated
applications and will be reviewed according to the customary peer review
procedures. The anticipated award date is September 30, 2004. Applications that
are not funded in the competition described in this RFA may be resubmitted as
NEW investigator-initiated applications using the standard receipt dates for NEW
applications described in the instructions to the PHS 398 application.
This RFA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically,
if you are submitting an application with direct costs in each year of $250,000
or less, use the modular budget format. Otherwise follow the instructions for
non-modular budget research grant applications. This program does not require
cost sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The NHLBI intends to commit approximately $3 million in FY 04 and a total of
$17.5 million over five years to fund three to six new grants in response to
this RFA. An applicant may request a project period of up to five years.
Because the nature and scope of the proposed research will vary from application
to application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the NHLBI provide support for this
program, awards pursuant to this RFA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution is domestic and has any
of the following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and
laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Faith-based or community-based organizations
o Foreign institutions are not eligible to apply
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out
the proposed research is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH programs.
SPECIAL REQUIREMENTS
THE FOLLOWING CRITERIA WILL GUIDE THE NHLBI STAFF IN DETERMINING RESPONSIVENESS
OF THE APPLICATIONS TO THIS RFA:
o Primary endpoint: Proportion of patients in the organization that achieve
blood pressure levels meeting JNC 7 recommendations.
o Patient Population: The primary endpoint should be measured in treated
hypertensive African American patients or, as specified under Goals and Scope
above, another group of treated hypertensive patients if local and/or national
data exist documenting both poor blood pressure control and disparately high
premature morbidity and/or mortality. Data on other patients may be evaluated
in secondary analyses and for comparative purposes.
o Interventions: Interventions should be delivered at the organization/clinic
level and be feasible (including cost) for implementation outside research
settings. NOTE: Interventions targeting exclusively patient-level variables
and/or limited to improving patient adherence to prescribed treatment will not
be responsive to this RFA.
o Study design: The study design should be concurrently controlled. A
randomized design is preferred – quasi-experimental designs are allowed if
strongly justified. Providers/clinics/organizations or patients may be
randomized. Detailed sample size calculations with assumptions should be
provided.
o Dissemination Plan: The purpose of this RFA is to improve translation of
knowledge into everyday clinical practice. Applicants must include in their
application a plan for dissemination of research results and of the
intervention. The latter will be implemented if the intervention is successful
and should aim to enhance utilization of the study intervention in clinical
practice. Such plan should include: identification and description of target
audience for the dissemination plan; description of methods to be used to reach
the audience; appropriate benchmarks for success; appropriate additional
personnel for developing and implementing the dissemination activities; an
appropriate budget for the proposed dissemination activities for the last year
of requested funding; a statement that the investigators agree to discuss and
finalize the dissemination plan with Institute staff prior to its
implementation. NOTE: Applications that do not include a dissemination plan will
be considered non-responsive and not eligible for review. Funds budgeted for
dissemination activities will be held in reserve until the final year of the
study and released only with the approval of the Institute. The dissemination
plan implementation can continue up to one year beyond the award period as a
no-cost extension.
THE FOLLOWING ARE SPECIAL REQUIREMENTS OF THIS RFA:
o Timelines: Funding will be provided for up to 5 years. Projects should
include an institutionalization phase with evaluation and a dissemination plan.
An initial planning phase may be included to refine interventions.
o Cost-effectiveness analysis: Must be included and budgeted for in the
application.
o Blood sample collection: Applicants who are planning to collect blood samples
for genetic, pharmacogenetic or other ancillary studies must describe blood
sample collection and storage for the duration of the trial, and budget for
these activities.
o Informed Consent: Applications should describe how informed consent will be
obtained and include a sample consent form (does not have to be approved by the
IRB). If the application includes plans for future genetic or other ancillary
studies, such plans should be included in the consent form, which may be tiered
to allow participation in the main study for individuals who refuse
participation in the blood sample collection.
o Monitoring Plan: Applications should include a data and safety monitoring
plan. A Data and Safety Monitoring Board (DSMB) appointed by the participating
Institution is required and should be budgeted for. Please see "Establishing
Data and Safety Monitoring Boards and Observational Study Monitoring Boards"
and "Responsibilities of DSMBs Appointed by Participating Institutions" under
"NHLBI Clinical Research" at http://www.nhlbi.nih.gov/funding/policies/index.htm.
o Recruitment: Recruitment plans should be described and documented to the
extent possible.
o Meetings: Investigators from each research project will be required to attend
annual meetings in the Washington, DC metropolitan area. The travel budget
should therefore reflect appropriate allocation for this activity.
o Data sharing: Applicants seeking $500K or more in direct costs in any year of
the project period are expected to include a data sharing-plan in their
applications stating how they will share the data or, if they cannot share the
data, why not. Reviewers will assess the adequacy of the proposed plan. More
information on data sharing can be found at
http://grants.nih.gov/grants/policy/data_sharing/.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Paula T. Einhorn, M.D., M.S.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8111
Bethesda, MD 20892-7936
Telephone: (301) 435-0563
FAX: (301)480-1669
Email: einhornp@nhlbi.nih.gov
o Direct your questions about peer review issues to:
Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892 – 7924
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: clarka@nhlbi.nih.gov
o Direct your questions about financial or grants management matters to:
Mr. Kieran Kelley
Senior Grants Management Specialist
Division of Extramural Affairs
National Heart, Lung, and Blood Institute/NIH
6701 Rockledge Drive, Room 7170
Bethesda, Maryland 20892-7926
Telephone: (301) 435-0154
FAX: (301)-480-3310 (fax
Email: email: kelleyk@nhlbi.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes the
following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to Anne Clark, Ph.D. at the
address listed under WHERE TO SEND INQUIRIES.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a DUN and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal
Identifier when applying for Federal grants or cooperative agreements. The DUNS
number can be obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com. The DUNS number should be entered on line 11
of the face page of the PHS 398 form. The PHS 398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up
to $250,000 per year in direct costs must be submitted in a modular budget grant
format. The modular budget grant format simplifies the preparation of the
budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the research
grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes
step-by-step guidance for preparing modular budget grants. Additional
information on modular budget grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label could
result in delayed processing of the application such that it may not reach the
review committee in time for review. In addition, the RFA title and number must
be typed on line 2 of the face page of the application form and the YES box must
be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the Checklist, and three signed, photocopies, in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application plus all
five collated sets of appendix material must be sent to Anne Clark, Ph.D. at the
address listed under WHERE TO SEND INQUIRIES.
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an application
is received after that date, it will be returned to the applicant without
review.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8
weeks.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA, it
is to be prepared as a NEW application. That is, the application for the RFA
must not include an Introduction describing the changes and improvements made,
and the text must not be marked to indicate the changes from the previous
unfunded version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NHLBI. Incomplete applications will not be reviewed.
If the application is not responsive to the RFA, NIH staff may contact the
applicant to determine whether to return the application to the applicant or
submit it for review in competition with unsolicited applications at the next
appropriate NIH review cycle.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the National Heart, Lung, and Blood Institute in accordance with the review
criteria stated below. As part of the initial merit review, all applications
will:
o Undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review, will
be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Heart, Lung, and Blood Institute
Advisory Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to evaluate the application in order
to judge the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals and the specific goals of this RFA. The
scientific review group will address and consider each of the following
criteria in assigning the application's overall score, weighting them as
appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of the
application are achieved, how will scientific knowledge be advanced? What will
be the effect of these studies on the concepts or methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project? Is the
proposed intervention appropriate for the proposed clinical setting and
culturally sensitive to the patient population? Does the applicant acknowledge
potential problem areas and consider alternative tactics? Are the
institutionalization and dissemination plans (including evaluation) appropriate
for the proposed settings? Is cost-effectiveness analysis appropriate for the
intended utilization of the program?
INNOVATION: Does the project employ novel concepts, approaches or methods? Are
the aims original and innovative? Does the project challenge existing paradigms
or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. (See criteria included in the section
on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans
to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs
in any year of the proposed research must include a data sharing plan in their
application. The reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However, reviewers
will not factor the proposed data sharing plan into the determination of
scientific merit or priority score. See
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html for guidance.
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: December 23, 2003
Application Receipt Date: January 20, 2004
Peer Review Date: June, 3004
Council Review: September 2, 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against these
risks, the potential benefits of the research to the subjects and others, and
the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all
types of clinical trials, including physiologic, toxicity, and dose-finding
studies (phase I); efficacy studies (phase II); efficacy, effectiveness and
comparative trials (phase III). The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risk to the participants. (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $500,000 or more
in direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing . Investigators should
seek guidance from their institutions, on issues related to institutional
policies, local IRB rules, as well as local, state and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on
October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that:
a) all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and
b) investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects.
You will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to provide
public access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health Information", the
"Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996
that governs the protection of individually identifiable health information,
and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule as
"covered entities") must do so by April 14, 2003 (with the exception of small
health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with
the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for
NIH funding must be self-contained within specified page limitations. Unless
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not
be used to provide information necessary to the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting priority areas. This RFA is related to
one or more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) CFDA
93.837 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.